System and method for controlling neurostimulation according to user activity and clinician rule-based scheduling of stimulation programs

ABSTRACT

This application is generally related to systems and methods for providing a medical therapy to a patient by tracking patient activity and adjusting medical therapy based on occurrence of different types of activities performed by the patient according to clinician defined stimulation program scheduling rules.

BACKGROUND

Smartphones and smartwatches include a number of components that permittracking of the activity of users of the devices. For example,smartphones commonly include global positioning system (GPS) components,accelerometers, and other sensors. The components of these have beenused to track a number of activities including exercise activities, usersleep patterns, health conditions, driving, and other common useractivities. Metrics for these various activities are commonly calculatedby one or more applications on these devices and can be provided to theusers to help guide their activities and to provide an assessment of thehealth of the patients.

The FITBIT VERSA SMARTWATCH™, SAMSUNG GALAXY SMARTWATCH™, and APPLEWATCH™ devices are example commercially available devices that includeaccelerometers, temperature sensors, heart rate monitors,electrocardiogram sensors, blood oxygen saturation sensors, and othersensors to provide users a summary of daily activities and overallanalysis of the activities.

More advanced tracking of specific disorders has begun usingcommercially available devices. For example, APPLE has developed a“MOVEMENT DISORDER” application programming interface (API) to allowmonitoring of movement disorder symptoms. The software collects datafrom the APPLE WATCH™ of a patient and analyzes the movement data todetect and quantify common symptoms of Parkinson's Disease (PD). Therelevant symptoms include tremors, indicated by shaking and quiveringand dyskinesia (a side-effect of pharmacological treatments of PD thatcauses fidgeting and swaying motions in patients).

Additionally, U.S. Pat. No. 10,314,550 describes using smartphonesand/or smartwatch type devices to monitor for possible mental orphysical health concerns. The patient tracking in the '550 patentautomatically learns user activity patterns and detects significantdeviations therefrom. The deviations are automatically analyzed forknown correlations to mental or physical concerns. The deviations may beprovided to medical professionals to assist provisional of medical careto the patient or to caretakers responsible for the respective patients.

Neurostimulation systems are systems that apply electrical stimulationto one or more targets of a patient's neural tissues to treatneurological disorders or other disorders of patients. It has beenproposed to use external devices (such as “fitness tracking” devices) totrack patient response to neurostimulation to determine whether theneurostimulation therapy is achieving an improvement in patientcondition and/or quality of life. Although fitness tracking andsmartwatches have been suggested to augment conventional patientcontroller devices for neurostimulation systems, many proposed designsmerely augment conventional external patient controller devices ratherthan provide new neurostimulation system capabilities.

SUMMARY

In some embodiments, systems and methods provide neurostimulation to apatient by monitoring activities of the patient using at least oneexternal device. Activities of the patient are monitored and detectedusing one or more sensors of an implantable device or an externaldevice. The sensors may include sensors for sensing physiologicalconditions, sensors for detection movement or location, and/or any othersuitable sensors. In some embodiments, an activity profile for thepatient is determined that represents expected times when the patientwill engage in a plurality of different activities of the patient.

In some embodiments, patient activity is detected using locationdetermining circuitry and location-based algorithms to correlatelocation to activity. Microlocation processing algorithms may beemployed to determine patient activity within the patient's domicile asone example. The monitoring of activities of a patient may includerepetitively detecting a location of the patient using locationdetermining circuitry of the external device of the patient. Thecircuitry for location-based activity tracking may including cellularcommunication circuitry, WiFi circuitry, and Bluetooth circuitry.Location-based activity detection may include detecting an amount oftime spent at an identified location.

In some embodiments, monitoring activities of the patient may compriseobtaining data pertaining to physiological signals of the patient usinga wearable device or an implanted device. The physiological signals mayinclude heart rate data, electrocardiogram data, a sleep quality data,body temperature data, blood oxygen saturation data, and blood glucosedata.

In some embodiments, the neurostimulation system includes an externalcontroller that receives user input from the patient by the externalcontroller that is indicative of patient activities being performed bythe patient. The patient may provide user input by selecting respectiveones of activity icons displayed on or more user interface screens whereeach respective icon represents a distinct patient activity. The userinterface screen(s) may receive input from the user indicative of easeor difficulty for the patient in performing a respective activity. Also,the user interface(s) may receive input from the user indicative of alevel of pain experienced by the patient at a respective point in time.

In some embodiments, a patient activity profile is generated from theactivity data collected from the implanted and/or external devices ofthe patient. In some embodiments, the patient activity data iscommunicated to a remote care management system, wherein the remote caremanagement system determines the activity profile for the patient. Theremote care management system may perform an averaging calculation ofobserved times for patient activities of the activity profile; calculateaverage start times of respective activities for the activity profile;may calculate average end times of respective activities for theactivity profile; apply a calculation of frequency of performance ofactivities to determine the activity profile; and/or apply an averagingcalculation to determine average duration of activities for the activityprofile. Such suitable processing of patient activity data into activitymetrics may be employed to create a patient activity profile.

The neurostimulation system may store a plurality of differentstimulation programs for use by a neurostimulation system of the patientsuch that each stimulation program is adapted to provide a differentstimulation effect on the patient. The different stimulation programsmay comprise different stimulation amplitude levels for application ofelectrical pulses to the patient. The different stimulation programs areadapted to provide a beneficial stimulation therapy specific to thepatient. The different stimulation programs may apply electrical pulsesat different frequencies. The different stimulation programs may applyelectrical pulses to different neural targets. The different stimulationprograms may apply electrical pulses using different stimulationpatterns. The different stimulation programs may cause different sideeffects for the patient. One of the different stimulation programs maybe adapted to modify blood flow to a region of the patient's body orotherwise modify cardiac activity of the patient. One of the differentstimulation programs may adapted to treat pain of the patient or treat amotor disorder symptom of the patient.

The implantable pulse generator of the neurostimulation system iscontrolled to generate electrical pulses according to ones of theplurality of different stimulation programs with different stimulationeffects for application to neural tissue of the patient according toactivities of the patient. In some embodiments, stimulation programs areapplied according to times defined by at least the activity profile ofthe patient.

In some embodiments, the neurostimulation system retrieves a stimulationscheduling parameter that defines a percentage or length of time forscheduling an identified stimulation program and dynamically adjustingscheduling of the identified stimulation program based on detectedactivities of the patient subject to scheduling compliance with thestimulation scheduling parameter.

In some embodiments, a scheduling process of the neurostimulation systemdetects when the patient engages in an activity outside of times definedin a patient profile and automatically reschedules selection of one ormore of the stimulation programs for generation of electrical pulses bythe implantable pulse generator. The scheduling process may detectperformance of a non-regular activity of the patient that is performedat varied times and switches application of stimulation programs by theimplantable pulse generator by detecting performance of the non-regularactivity.

The scheduling process may resume a respective stimulation program for aregularly performed activity when the stimulation scheduling processdetects an end point of the non-regularly activity of the patient. Thescheduling process may detect early performance of an otherwiseregularly performed activity and automatically reschedules an end timefor a respective stimulation program for the regularly performedactivity. The scheduling process may detect termination of an activityrepresented in the activity profile at a time later than expected andreschedules stimulation for one or more stimulation programs ofsubsequent activities defined in the activity profile. When thescheduling process detects performance of an activity outside of a timeperiod defined in the activity profile of the patient, the schedulingprocess may select a stimulation program corresponding to activity beingperformed outside of a time period defined in the activity profile, anda balancing process modifies timing of application of one or more otherstimulation programs to balance performance of stimulation programsaccording to one or more clinician set parameters.

In some embodiments, the neurostimulation system stores a plurality ofclinician defined scheduling rules that define time periods forprovision of stimulation according to ones of the plurality of differentstimulation programs based on performance of respective activitiesperformed by the patient. A scheduling process of the neurostimulationsystem controls when an implantable pulse generator of theneurostimulation system generates electrical pulses according to ones ofthe plurality of different stimulation programs with differentstimulation effects for application to neural tissue of the patientaccording to times defined by at least the activity profile and thescheduling rules.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a neurostimulation system according to some embodiments.

FIG. 2 depicts a computing device that may be included within aneurostimulation system or to communicate with a neurostimulation systemaccording to some embodiments.

FIG. 3 depicts a network environment for remote management of patientcare according to some embodiments.

FIG. 4 depicts a user interface that provides a number of icons thatrepresent activities of the patient according to some embodiments.

FIG. 5 depicts a user interface for receiving additional patient dataaccording to some embodiments.

FIG. 6 depicts a flowchart for aggregating and processing patientactivity data to manage patient care according to some embodiments.

FIG. 7 depicts a patient activity graph according to one representativeembodiment.

FIG. 8 depicts a flowchart of activities and operations to employpatient activity data to develop a stimulation therapy with stimulationparameters selected according to different patient activities.

FIG. 9 depicts a flowchart of activities and operations to create astimulation schedule based on expected user activities according to someembodiments.

FIG. 10 depicts a series of operations that may be performed by apatient controller device or a remote server to control neurostimulationapplied to a patient according to some embodiments.

DETAILED DESCRIPTION

Neurostimulation systems are devices that generate electrical pulses anddeliver the pulses to neural tissue of a patient to treat a variety ofdisorders. One category of neurostimulation systems is deep brainstimulation (DBS). In DBS, pulses of electrical current are delivered totarget regions of a subject's brain, for example, for the treatment ofmovement and effective disorders such as PD and essential tremor.Another category of neurostimulation systems is spinal cord stimulation(SCS) which is often used to treat chronic pain such as Failed BackSurgery Syndrome (FBSS) and Complex Regional Pain Syndrome (CRPS). SCSdevices may also treat a number of other disorders in addition tochronic pain. Dorsal root ganglion (DRG) stimulation is another exampleof a neurostimulation therapy in which electrical stimulation isprovided to the dorsal root ganglion structure that is just outside ofthe epidural space. DRG stimulation is also generally used to treatchronic pain but may treat other disorders. Neurostimulation therapiesincluding SCS stimulation and DRG stimulation are also known to effectother physiological processes such as cardiac, respiratory, anddigestive processes as examples.

Neurostimulation systems generally include a pulse generator and one ormore leads. A stimulation lead includes a lead body of insulativematerial that encloses wire conductors. The distal end of thestimulation lead includes multiple electrodes, or contacts, thatintimately impinge upon patient tissue and are electrically coupled tothe wire conductors. The proximal end of the lead body includes multipleterminals (also electrically coupled to the wire conductors) that areadapted to receive electrical pulses. In DBS systems, the distal end ofthe stimulation lead is implanted within the brain tissue to deliver theelectrical pulses. The stimulation leads are then tunneled to anotherlocation within the patient's body to be electrically connected with apulse generator or, alternatively, to an “extension.” The pulsegenerator is typically implanted in the patient within a subcutaneouspocket created during the implantation procedure.

The pulse generator is typically implemented using a metallic housing(or “can”) that encloses circuitry for generating the electricalstimulation pulses, control circuitry, communication circuitry, arechargeable or primary cell battery, etc. The pulse generatingcircuitry is coupled to one or more stimulation leads through electricalconnections provided in a “header” of the pulse generator. Specifically,feedthrough wires typically exit the metallic housing and enter into aheader structure of a moldable material. Within the header structure,the feedthrough wires are electrically coupled to annular electricalconnectors. The header structure holds the annular connectors in a fixedarrangement that corresponds to the arrangement of terminals on theproximal end of a stimulation lead.

Stimulation system 100 is shown in FIG. 1 according to some embodiments.Stimulation system 100 generates electrical pulses for application totissue of a patient to treat one or more disorders of the patient.System 100 includes an implantable pulse generator (IPG) 150 that isadapted to generate electrical pulses for application to tissue of apatient. Examples of commercially available implantable pulse generatorsinclude the PROCLAIM XR™ and INFINITY™ implantable pulse generators(available from ABBOTT, PLANO Tex.). Alternatively, system 100 mayinclude an external pulse generator (EPG) positioned outside thepatient's body. IPG 150 typically includes a metallic housing (or can)that encloses a controller 151, pulse generating circuitry 152, abattery 153, far-field and/or near field communication circuitry 154(e.g., BLUETOOTH communication circuitry), and other appropriatecircuitry and components of the device. Controller 151 typicallyincludes a microcontroller or other suitable processor for controllingthe various other components of the device. Software code is typicallystored in memory of IPG 150 for execution by the microcontroller orprocessor to control the various components of the device.

IPG 150 may comprise one or more attached extension components 170 or beconnected to one or more separate extension components 170.Alternatively, one or more stimulation leads 110 may be connecteddirectly to IPG 150. Within IPG 150, electrical pulses are generated bypulse generating circuitry 152 and are provided to switching circuitry.The switching circuit connects to output wires, metal ribbons, traces,lines, or the like (not shown) from the internal circuitry of pulsegenerator 150 to output connectors (not shown) of pulse generator 150which are typically contained in the “header” structure of pulsegenerator 150. Commercially available ring/spring electrical connectorsare frequently employed for output connectors of pulse generators (e.g.,“Bal-Seal” connectors). The terminals of one or more stimulation leads110 are inserted within connector portion 171 for electrical connectionwith respective connectors or directly within the header structure ofpulse generator 150. Thereby, the pulses originating from IPG 150 areconducted to electrodes 111 through wires contained within the lead bodyof lead 110. The electrical pulses are applied to tissue of a patientvia electrodes 111.

For implementation of the components within IPG 150, a processor andassociated charge control circuitry for an implantable pulse generatoris described in U.S. Pat. No. 7,571,007, entitled “SYSTEMS AND METHODSFOR USE IN PULSE GENERATION,” which is incorporated herein by reference.Circuitry for recharging a rechargeable battery of an implantable pulsegenerator using inductive coupling and external charging circuits aredescribed in U.S. Pat. No. 7,212,110, entitled “IMPLANTABLE DEVICE ANDSYSTEM FOR WIRELESS COMMUNICATION,” which is incorporated herein byreference.

An example and discussion of “constant current” pulse generatingcircuitry is provided in U.S. Patent Publication No. 2006/0170486entitled “PULSE GENERATOR HAVING AN EFFICIENT FRACTIONAL VOLTAGECONVERTER AND METHOD OF USE,” which is incorporated herein by reference.One or multiple sets of such circuitry may be provided within IPG 150.Different pulses on different electrodes may be generated using a singleset of pulse generating circuitry using consecutively generated pulsesaccording to a “multi-stimset program” as is known in the art.Alternatively, multiple sets of such circuitry may be employed toprovide pulse patterns that include simultaneously generated anddelivered stimulation pulses through various electrodes of one or morestimulation leads as is also known in the art. Various sets ofparameters may define the pulse characteristics and pulse timing for thepulses applied to various electrodes as is known in the art. Althoughconstant current pulse generating circuitry is contemplated for someembodiments, any other suitable type of pulse generating circuitry maybe employed such as constant voltage pulse generating circuitry.

Stimulation lead(s) 110 may include a lead body of insulative materialabout a plurality of conductors within the material that extend from aproximal end of lead 110 to its distal end. The conductors electricallycouple a plurality of electrodes 111 to a plurality of terminals (notshown) of lead 110. The terminals are adapted to receive electricalpulses and the electrodes 111 are adapted to apply stimulation pulses totissue of the patient. Also, sensing of physiological signals may occurthrough electrodes 111, the conductors, and the terminals. Additionallyor alternatively, various sensors (not shown) may be located near thedistal end of stimulation lead 110 and electrically coupled to terminalsthrough conductors within the lead body 172. Stimulation lead 110 mayinclude any suitable number and type of electrodes 111, terminals, andinternal conductors.

External controller device 160 is a device that permits the operationsof IPG 150 to be controlled by a user after IPG 150 is implanted withina patient. Also, multiple controller devices may be provided fordifferent types of users (e.g., the patient or a clinician). Controllerdevice 160 can be implemented by utilizing a suitable handheldprocessor-based system that possesses wireless communicationcapabilities. Software is typically stored in memory of controllerdevice 160 to control the various operations of controller device 160.The interface functionality of controller device 160 is implementedusing suitable software code for interacting with the user and using thewireless communication capabilities to conduct communications with IPG150. One or more user interface screens may be provided in software toallow the patient and/or the patient's clinician to control operationsof IPG 150 using controller device 160. In some embodiments,commercially available devices such as APPLE iOS devices are adapted foruse as controller device 160 by include one or more “apps” thatcommunicate with IPG 150 using, for example, BLUETOOTH communication.

Controller device 160 preferably provides one or more user interfaces toallow the user to operate IPG 150 according to one or more stimulationprograms to treat the patient's disorder(s). Each stimulation programmay include one or more sets of stimulation parameters including pulseamplitude, pulse width, pulse frequency or inter-pulse period, pulserepetition parameter (e.g., number of times for a given pulse to berepeated for respective stimset during execution of program), etc.

Controller device 160 may permit programming of IPG 150 to provide anumber of different stimulation patterns or therapies to the patient asappropriate for a given patient and/or disorder. Examples of differentstimulation therapies include conventional tonic stimulation (continuoustrain of stimulation pulses at a fixed rate), BurstDR stimulation (burstof pulses repeated at a high rate interspersed with quiescent periodswith or without duty cycling), “high frequency” stimulation (e.g., acontinuous train of stimulation pulses at 10,000 Hz), noise stimulation(series of stimulation pulses with randomized pulse characteristics suchas pulse amplitude to achieve a desired frequency domain profile). Anysuitable stimulation pattern or combination thereof can be provided byIPG 150 according to some embodiments. Controller device 160communicates the stimulation parameters and/or a series of pulsecharacteristics defining the pulse series to be applied to the patientto IPG 150 to generate the desired stimulation therapy.

Examples of suitable therapies include tonic stimulation (in which afixed frequency pulse train) is generated, burst stimulation (in whichbursts of multiple high frequency pulses) are generated which in turnare separated by quiescent periods, “high frequency” stimulation,multi-frequency stimulation, and noise stimulation. Descriptions ofrespective neurostimulation therapies are provided in the followingpublications: (1) Schu S., Slotty P. J., Bara G., von Knop M., Edgar D.,Vesper J. A Prospective, Randomised, Double-blind, Placebo-controlledStudy to Examine the Effectiveness of Burst Spinal Cord StimulationPatterns for the Treatment of Failed Back Surgery Syndrome.Neuromodulation 2014; 17: 443-450; (2) Al-Kaisy A1, Van Buyten J P, SmetI, Pal isani S, Pang D, Smith T. 2014. Sustained effectiveness of 10 kHzhigh-frequency spinal cord stimulation for patients with chronic, lowback pain: 24-month results of a prospective multicenter study. PainMed. 2014 March; 15(3):347-54; and (3) Sweet, Badjatiya, Tan D1, Miller.Paresthesia-Free High-Density Spinal Cord Stimulation forPostlaminectomy Syndrome in a Prescreened Population: A Prospective CaseSeries. Neuromodulation. 2016 April; 19(3):260-7. Noise stimulation isdescribed in U.S. Pat. No. 8,682,441B2. Burst stimulation is describedin U.S. Pat. No. 8,224,453 and U.S. Published Application No.20060095088. A “coordinated reset” pulse pattern is applied to neuronalsubpopulation/target sites to desynchronize neural activity in thesubpopulations. Coordinated reset stimulation is described, for example,by Peter A. Tass et al in COORDINATED RESET HAS SUSTAINED AFTER EFFECTSIN PARKINSONIAN MONKEYS, Annals of Neurology, Volume 72, Issue 5, pages816-820, November 2012, which is incorporated herein by reference. Theelectrical pulses in a coordinated reset pattern are generated in burstsof pulses with respective bursts being applied to tissue of the patientusing different electrodes in a time-offset manner. The time-offset isselected such that the phase of the neural-subpopulations are reset in asubstantially equidistant phase-offset manner. By resetting neuronalsubpopulations in this manner, the population will transition to adesynchronized state by the interconnectivity between the neurons in theoverall neuronal population. All of these references are incorporatedherein by reference.

For implementation of the components within IMD 14, a processor andassociated charge control circuitry for an implantable pulse generatoris described in U.S. Pat. No. 7,571,007, entitled “SYSTEMS AND METHODSFOR USE IN PULSE GENERATION,” which is incorporated herein by reference.Circuitry for recharging a rechargeable battery of an implantable pulsegenerator using inductive coupling and external charging circuits aredescribed in U.S. Pat. No. 7,212,110, entitled “IMPLANTABLE DEVICE ANDSYSTEM FOR WIRELESS COMMUNICATION” which is incorporated herein byreference.

IPG 150 modifies its internal parameters in response to the controlsignals from controller device 160 to vary the stimulationcharacteristics of stimulation pulses transmitted through stimulationlead 110 to the tissue of the patient. Neurostimulation systems,stimsets, and multi-stimset programs are discussed in PCT PublicationNo. WO 2001/093953, entitled “NEUROMODULATION THERAPY SYSTEM,” and U.S.Pat. No. 7,228,179, entitled “METHOD AND APPARATUS FOR PROVIDING COMPLEXTISSUE STIMULATION PATTERNS,” which are incorporated herein byreference.

External charger device 165 may be provided to recharge battery 153 ofIPG 150 according to some embodiments when IPG 150 includes arechargeable battery. External charger device 165 comprises a powersource and electrical circuitry (not shown) to drive current throughcoil 166. The patient places the primary coil 166 against the patient'sbody immediately above the secondary coil (not shown), i.e., the coil ofthe implantable medical device. Preferably, the primary coil 166 and thesecondary coil are aligned in a coaxial manner by the patient forefficiency of the coupling between the primary and secondary coils. Inoperation during a charging session, external charger device 165generates an AC-signal to drive current through coil 166 at a suitablefrequency. Assuming that primary coil 166 and secondary coil aresuitably positioned relative to each other, the secondary coil isdisposed within the magnetic field generated by the current driventhrough primary coil 166. Current is then induced by a magnetic field inthe secondary coil. The current induced in the coil of the implantablepulse generator is rectified and regulated to recharge the battery ofIPG 150. IPG 150 may also communicate status messages to externalcharging device 165 during charging operations to control chargingoperations. For example, IPG 150 may communicate the coupling status,charging status, charge completion status, etc.

System 100 may include external wearable device 170 such as a smartwatchor health monitor device. Wearable device may be implemented usingcommercially available devices such as FITBIT VERSA SMARTWATCH™, SAMSUNGGALAXY SMARTWATCH™, and APPLE WATCH™ devices with one or more apps orappropriate software to interact with IPG 150 and/or controller device160. In some embodiments, wearable device 170, controller device 160,and IPG 150 conduct communications using BLUETOOTH communications.

Wearable device 170 monitors activities of the patient and/or sensesphysiological signals. Wearable device 170 may track physical activityand/or patient movement through accelerometers. Wearable device 170 maymonitory body temperature, heart rate, electrocardiogram activity, bloodoxygen saturation, and/or the like. Wearable device 170 may monitorsleep quality or any other relevant health related activity.

Wearable device 170 may provide one or more user interface screens topermit the patient to control or otherwise interact with IPG 150. Forexample, the patient may increase or decrease stimulation amplitude,change stimulation programs, turn stimulation on or off, and/or the likeusing wearable device 170. Also, the patient may check the batterystatus of other implant status information using wearable device 170.

Wearable device 170 may include one or more interface screens to receivepatient input. In some embodiments, wearable device 170 and/orcontroller device 160 are implemented (individually or in combination)to provide an electronic patient diary function. The patient diaryfunction permits the patient to record on an ongoing basis the healthstatus of the patient and the effectiveness of the therapy for thepatient. In some embodiments as discussed herein, wearable device 170and/or controller device 160 enable the user to indicate the currentactivity of the patient, the beginning of an activity, the completion ofan activity, the ease or quality of patient's experience with a specificactivity, the patient's experience of pain, the patient's experience ofrelief from pain by the stimulation, or any other relevant indication ofpatient health by the patient.

FIG. 2 is a block diagram of one embodiment of a computing device 200that may be used to according to some embodiments. Computing device 200may be used to implement external controller device 160, wearable device170, remote care management servers, or other computing system accordingto some embodiments.

Computing device 200 includes at least one memory device 210 and aprocessor 215 that is coupled to memory device 210 for executinginstructions. In some embodiments, executable instructions are stored inmemory device 210. In some embodiments, computing device 200 performsone or more operations described herein by programming processor 215.For example, processor 215 may be programmed by encoding an operation asone or more executable instructions and by providing the executableinstructions in memory device 210.

Processor 215 may include one or more processing units (e.g., in amulti-core configuration). Further, processor 215 may be implementedusing one or more heterogeneous processor systems in which a mainprocessor is present with secondary processors on a single chip. Inanother illustrative example, processor 215 may be a symmetricmulti-processor system containing multiple processors of the same type.Further, processor 215 may be implemented using any suitableprogrammable circuit including one or more systems and microcontrollers,microprocessors, reduced instruction set circuits (RISC), applicationspecific integrated circuits (ASIC), programmable logic circuits, fieldprogrammable gate arrays (FPGA), and any other circuit capable ofexecuting the functions described herein.

In the illustrated embodiment, memory device 210 is one or more devicesthat enable information such as executable instructions and/or otherdata to be stored and retrieved. Memory device 210 may include one ormore computer readable media, such as, without limitation, dynamicrandom access memory (DRAM), read-only memory (ROM), electricallyerasable programmable read-only memory (EEPROM), static random accessmemory (SRAM), a solid state disk, and/or a hard disk. Memory device 210may be configured to store, without limitation, application source code,application object code, source code portions of interest, object codeportions of interest, configuration data, execution events and/or anyother type of data.

Computing device 200, in the illustrated embodiment, includes acommunication interface 240 coupled to processor 215. Communicationinterface 240 communicates with one or more remote devices, such as aclinician or patient programmer. To communicate with remote devices,communication interface 240 may include, for example, a wired networkadapter, a wireless network adapter, a radio-frequency (RF) adapter,and/or a mobile telecommunications adapter.

FIG. 3 depicts a network environment 300 for remote management ofpatient care. One or more embodiments of a remote care therapyapplication or service may be implemented in network environment 300, asdescribed herein. In general, “remote care therapy” may involve anycare, biomedical monitoring, or therapy that may be provided by aclinician, a medical professional or a healthcare provider, and/or theirrespective authorized agents (including digital/virtual assistants),with respect to a patient over a communications network while thepatient and the clinician/provider are not in close proximity to eachother (e.g., not engaged in an in-person office visit or consultation).Accordingly, in some embodiments, a remote care therapy application mayform a telemedicine or a telehealth application or service that not onlyallows healthcare professionals to use electronic communications toevaluate, diagnose and treat patients remotely, thereby facilitatingefficiency as well as scalability, but also provides patients withrelatively quick and convenient access to diversified medical expertisethat may be geographically distributed over large areas or regions, viasecure communications channels as described herein.

Network environment 300 may include any combination or sub-combinationof a public packet-switched network infrastructure (e.g., the Internetor worldwide web, also sometimes referred to as the “cloud”), privatepacket-switched network infrastructures such as Intranets and enterprisenetworks, health service provider network infrastructures, and the like,any of which may span or involve a variety of access networks, backhauland core networks in an end-to-end network architecture arrangementbetween one or more patients, e.g., patient(s) 302, and one or moreauthorized clinicians, healthcare professionals, or agents thereof,e.g., generally represented as caregiver(s) or clinician(s) 338.

Example patient(s) 302, each having a suitable implantable device 303,may be provided with a variety of corresponding external devices forcontrolling, programming, otherwise (re)configuring the functionality ofrespective implantable medical device(s) 303, as is known in the art.Such external devices associated with patient(s) 302 are referred toherein as patient devices 304, and may include a variety of userequipment (UE) devices, tethered or untethered, that may be configuredto engage in remote care therapy sessions. By way of example, patientdevices 304 may include smartphones, tablets or phablets,laptops/desktops, handheld/palmtop computers, wearable devices such assmart glasses and smart watches, personal digital assistant (PDA)devices, smart digital assistant devices, etc., any of which may operatein association with one or more virtual assistants, smart home/officeappliances, smart TVs, virtual reality (VR), mixed reality (MR) oraugmented reality (AR) devices, and the like, which are generallyexemplified by wearable device(s) 306, smartphone(s) 308,tablet(s)/phablet(s) 310 and computer(s) 312. As such, patient devices304 may include various types of communications circuitry or interfacesto effectuate wired or wireless communications, short-range andlong-range radio frequency (RF) communications, magnetic fieldcommunications, Bluetooth communications, etc., using any combination oftechnologies, protocols, and the like, with external networked elementsand/or respective implantable medical devices 303 corresponding topatient(s) 302.

With respect to networked communications, patient devices 304 may beconfigured, independently or in association with one or moredigital/virtual assistants, smart home/premises appliances and/or homenetworks, to effectuate mobile communications using technologies such asGlobal System for Mobile Communications (GSM) radio access network(GRAN) technology, Enhanced Data Rates for Global System for MobileCommunications (GSM) Evolution (EDGE) network (GERAN) technology, 4GLong Term Evolution (LTE) technology, Fixed Wireless technology, 5thGeneration Partnership Project (SGPP or 5G) technology, IntegratedDigital Enhanced Network (IDEN) technology, WiMAX technology, variousflavors of Code Division Multiple Access (CDMA) technology,heterogeneous access network technology, Universal MobileTelecommunications System (UMTS) technology, Universal Terrestrial RadioAccess Network (UTRAN) technology, All-IP Next Generation Network (NGN)technology, as well as technologies based on various flavors of IEEE802.11 protocols (e.g., WiFi), and other access point (AP)-basedtechnologies and microcell-based technologies such as femtocells,picocells, etc. Further, some embodiments of patient devices 104 mayalso include interface circuitry for effectuating network connectivityvia satellite communications. Where tethered UE devices are provided aspatient devices 304, networked communications may also involve broadbandedge network infrastructures based on various flavors of DigitalSubscriber Line (DSL) architectures and/or Data Over Cable ServiceInterface Specification (DOCSIS)-compliant Cable Modem TerminationSystem (CMTS) network architectures (e.g., involving hybridfiber-coaxial (HFC) physical connectivity). Accordingly, by way ofillustration, an edge/access network portion 119A is exemplified withelements such as WiFi/AP node(s) 316-1, macro/microcell node(s) 116-2and 116-3 (e.g., including micro remote radio units or RRUs, basestations, eNB nodes, etc.) and DSL/CMTS node(s) 316-4.

Similarly, clinicians 338 may be provided with a variety of externaldevices for controlling, programming, otherwise (re)configuring orproviding therapy operations with respect to one or more patients 302mediated via respective implantable medical device(s) 303, in a localtherapy session and/or remote therapy session, depending onimplementation and use case scenarios. External devices associated withclinicians 338, referred to herein as clinician devices 330, may includea variety of UE devices, tethered or untethered, similar to patientdevices 304, which may be configured to engage in remote care therapysessions as will be set forth in detail further below. Clinician devices330 may therefore also include devices (which may operate in associationwith one or more virtual assistants, smart home/office appliances, VRARvirtual reality (VR) or augmented reality (AR) devices, and the like),generally exemplified by wearable device(s) 331, smartphone(s) 332,tablet(s)/phablet(s) 334 and computer(s) 336. Further, example cliniciandevices 330 may also include various types of network communicationscircuitry or interfaces similar to that of patient device 304, which maybe configured to operate with a broad range of technologies as set forthabove. Accordingly, an edge/access network portion 319B is exemplifiedas having elements such as WiFi/AP node(s) 328-1, macro/microcellnode(s) 328-2 and 328-3 (e.g., including micro remote radio units orRRUs, base stations, eNB nodes, etc.) and DSL/CMTS node(s) 328-4. Itshould therefore be appreciated that edge/access network portions 319A,319B may include all or any subset of wireless communication means,technologies and protocols for effectuating data communications withrespect to an example embodiment of the systems and methods describedherein.

In one arrangement, a plurality of network elements or nodes may beprovided for facilitating a remote care therapy service involving one ormore clinicians 338 and one or more patients 302, wherein such elementsare hosted or otherwise operated by various stakeholders in a servicedeployment scenario depending on implementation (e.g., including one ormore public clouds, private clouds, or any combination thereof). In oneembodiment, a remote care session management node 320 is provided, andmay be disposed as a cloud-based element coupled to network 318, that isoperative in association with a secure communications credentialsmanagement node 322 and a device management node 324, to effectuate atrust-based communications overlay/tunneled infrastructure in networkenvironment 300 whereby a clinician may advantageously engage in aremote care therapy session with a patient.

U.S. Pat. No. 10,124,177 discloses a system for conducting a remoteprogramming session for an implantable medical device of patient wherethe clinician operates a clinician programmer at a site that is remotefrom the location of the patient. U.S. Pat. No. 10,124,177 isincorporated herein by reference.

In the embodiments described herein, implantable medical device 303 maybe any suitable medical device. For example, implantable medical devicemay be a neurostimulation device that generates electrical pulses anddelivers the pulses to nervous tissue of a patient to treat a variety ofdisorders.

Although implantable medical device 303 is described in the context of aneurostimulation device herein, those of skill in the art willappreciate that implantable medical device 303 may be any type ofimplantable medical device.

In some embodiments, patient activity data is aggregated and processedto identify performance of patient activities. For example, locationdata ay be obtained using wearable device 170 and/or controller device160 to identify patient activity. For example, microlocation processingmay be employed to track the patient through the patient's residence.Microlocation uses BLUETOOTH beacon devices placed at known locations topermit tracking of an individual's location with a relatively degree ofprecision within an indoor environment. Additionally, details regardingmicrolocation processing may be found in: L. B. Das et al.,“Determination Of Microlocation Using the BLE Protocol, and WirelessSensor Networks,” 2018 IEEE 3rd International Conference on Computing,Communication and Security (ICCCS), Kathmandu, 2018, pp. 64-69, doi:10.1109/CCCS.2018.8586813 which is incorporated herein by reference. Themicrolocation processing may identify patient activity by identify timespend in specific areas. For example, a meal may be identified by thepatient spending time within the patient's dining area.

In some embodiments, other protocols are employed to identify activitiesof a patient. For example, global positioning system (GPS) circuitry mayobtain location data and processed. The GPS data may identify thepatient as being at the patient's work location and thereby identify thepatient activity as “WORKING” at such times. Also, the GPS data mayidentify the user as moving relatively rapidly thereby correlating thepatient activity to “COMMUTING” or “DRIVING” as the GPS data indicates.Methods for correlating activities of individuals to locations are knownin the art and described in, for example, the article Location-basedActivity Recognition by Lin Liao, Dieter Fox, and Henry Kautz in NeuralInformation Processing Systems (NIPS), 2005, which is incorporatedherein by reference.

In some embodiments, activity monitoring functionality of wearabledevice 170 may be employed to identify patient activity. For example,the sleep monitoring functionality may identify times of sleep by apatient from movement data, heart rate data, and other relevantphysiological data. Examples of sleep stage classification are describedin U.S. Pat. No. 10,786,676 and U.S. Patent App. Pub. No. 20050043652which are incorporated herein by reference.

The identification of patient activities may use the techniquesdescribed in U.S. Pat. No. 10,314,550 as an example.

In some embodiments, patient activity data may be directly identified bythe patient using wearable device 170 and/or controller device 160. Asshown in FIG. 4, user interface 400 provides a number of icons thatrepresent activities of the patient. User interface 400 may be providedby external controller 160. Similar icons could be provided by wearabledevice 170 although the presentation could be provided in a differentarrangement to accommodate to the typical smaller screen size ofwearable devices. The icons shown in FIG. 4 correspond to driving,working, eating, exercising, sleeping, resting, talking, and takingmedication. Any number of other icons could be provided to representother user activities. In some embodiments, the user and/or theclinician may select from a number of predefined activities for use on aspecific user's device as deemed most relevant to the patient and/or theclinician. Additionally, the icons include a “PAIN” symptom icon thatpermits the user to provide an indication of the amount of pain that thepatient is currently experiencing at any given time. If the stimulationsystem is intended to treat a condition other than chronic pain, thesymptom icon may reflect other conditions such as tremor, difficultymoving, dyskinesia, or other conditions. The icons available forselection by a user may be customizable according to some embodiments.For example, the patient or the patient's clinician may select icons foruse by the patient from a larger set of icons depending upon relevanceto the patient. Predefined sets of a plurality of icons may also bedefined for selection by the patient and/or the patient's clinician foruse by patient according to patient disorder (e.g., chronic pain,movement disorder, and/or other neurological disorders) and patientrelevant data (e.g., age, gender, health condition, etc.).

When the user begins, ends, or otherwise engages in an activity, theuser may select one of the icons. The user selection is recorded in anactivity log. Also, as shown in FIG. 5, user interface 500 may beprovided that presents additional options for selection by the user uponselection of one of the activity icons. The user may select an icon toindicate that the user has just begun the activity (“start”), or hascompleted the activity (“stop”). Also, the user may provide anindication of the relatively quality, ease, difficulty, etc. of theactivity for the patient by selecting the “RATING” icon. For example, ifthe user is experiencing difficulty completing the patient's workactivity, the patient may select a lower rating or score for theactivity.

The various user indications of activity and other user inputs arelogged and communicated to a remote care management system by externalcontroller device 160 and/or wearable device 170. The remote caremanagement system stores the user activity data. Also, externalcontroller device 160 and/or wearable device 170 may communicate useractivity data obtained by these devices using sensors or otherfunctionality of the devices.

FIG. 6 depicts a flowchart for aggregating and processing patientactivity data to manage patient care according to some embodiments. Instep 601, patient activity is obtained by external controller device 160and/or wearable device 170 using circuitry, sensors, and processingfunctionality of these devices. The patient activity data may includemovement data, sleep data heart rate data, electrocardiogram data, bodytemperature data, blood saturation data, and/or any other relevant dataavailable from these devices. Additionally, other data from othermedical devices may be gathered for use in accordance with someembodiments. For example, the glucose monitoring devices generate datarelated to the amount of glucose in the patient's blood stream. Glucosemonitoring devices include the FREESTYLE LIBRE glucose monitor deviceavailable from ABBOTT. In 602, the patient data is communicated to aremote care management system where it is stored for a given patient.

In 603, user indications of patient activity are gathered by externalcontroller device 160 and/or wearable device 170. The patient data mayinclude indications of levels of difficulty or ease associated withspecific activity, start times, stop times, pain or other symptomlevels, and/or any other relevant data. In 604, the patient inputteddata is communicated to a remote care management system where it isstored for a given patient.

In 605, the data is made available to the patient's clinician(s) and/orcaretaker(s). The clinicians may review the data to make decisions tomodify the patient's neurostimulation therapy or provide other suitablemedical or health care for the patient. The data may be made availableby providing reports of the patient activity in graphical format whenthe clinician accesses patient data through a session with the remotecare management system.

In 606, the remote care system generates one or more activity profilesfor the patient that depicts average times of activities for the patientbased on observed data. The average times may also be determined suchthat a separate profile is developed for each day of the week.

In 607, one or more patient activity profiles are provided to theclinician to make decisions to modify the patient's neurostimulationtherapy or provide other suitable medical or health care for thepatient. The data may be made available by providing reports of thepatient profile(s) in graphical format when the clinician accessespatient data through a session with the remote care management system.

In 608, one or more of the patient profiles are downloaded to thepatient's external controller device 160 and/or wearable device 170according to some embodiments. In some embodiments, the patient'sneurostimulation therapy may be controlled based on patient activitiesand/or the patient's activity profile.

FIG. 7 depicts patient activity graph 700 according to onerepresentative embodiment. The patient activity graph 700 may representthe actual activities detected for a patient on a given day.Alternatively, the graph may represent activities for a statisticallyaverage day for a given patient. Graph 700 shown the actual times orexpected times for each representative activity. Also, graph 700 depictssymptom severity representation 701. Symptom severity representation 701may, for example, represent an interpolated graph of the pain reportpain scores through the day. The clinician may use the representation ofthe patient's pain to control the neurostimulation provided to thepatient. Also, the clinician may identify relationships between patientpain and specific activities.

In some embodiments, the clinician may select a point in time alonggraph 700 and view any patient reported activity and/or anyphysiological or other data captured by wearable device 170 and/orexternal controller 160. For example, the clinician may review patientsleep quality to identify relationships between the patient's conditionand other external factors or activities. The clinician may review heartrate or other cardiac activity data, body temperature data, bloodglucose levels, blood oxygen levels, or any other measured physiologicaldata according to some embodiments. In some embodiments, the clinicianmay select an option to display physiological data overlaying theactivities of the patient. For example, as depicted in FIG. 7, graph 702represents a time-window averaged heart rate of the patient atrespective times. Any of physiological or other signals described hereincould be displayed in a similar manner at the option of the clinicianwhen conducting a session with the remote care management system toreview patient activity data. As previously discussed, graph 702 couldrepresent actual measurement data for a specific day or averagephysiological data depending upon whether the clinician wishes to reviewdata for a specific date or review the patient's profile.

FIG. 8 depicts a flowchart of activities and operations to employpatient activity data to develop a stimulation therapy with stimulationparameters selected according to different patient activities. In 801, aclinician reviews patient condition data and patient activities. In 802,the clinician identifies activities associated with unacceptable patientconditions, symptoms, or the like. The patient condition data mayinclude objectively measured data such as data related to patientmovement (movement disorder symptoms), cardiac activity, EMG data,respiration data, blood glucose data, and/or any other sensed data. Thepatient condition data may include subjectively captured data such aspatient indicated data from the patient's controller device. Thesubjective data may include pain levels, difficulty performing tasks,psychological data (e.g., affect levels, anxiety levels, etc.), or anyother relevant patient reported information.

In 803, clinician selects therapy parameters for multiple stimulationprograms to address patient conditions, symptoms, or the like observedfor different patient activities. For example, the clinician may observethat the patient experiences higher pain levels while working or walkingas examples. The clinician may define an additional stimulation programbeyond a default stimulation program to address the higher level of painduring such activities. As another example, the clinician may observethat the patient experiences some level of difficulty swallowing when astimulation program adapted to achieve optimally motor disorder symptomsuppression occurs. The clinician may define an additional stimulationprogram to reduce this side-effect while still achieve an acceptable butlower degree of motor disorder symptom suppression for use when thepatient is eating a meal.

In some embodiments, the stimulation pattern applied to the patient viadifferent stimulation programs may differ. For example, “coordinatedreset” stimulation and tonic stimulation have both been applied forParkinson's Disease. Although coordinated reset stimulation is suggestedto have some clinical benefits to restore a patient's neural activity toa natural non-synchronized state from a pathological synchronized state,tonic stimulation may have a more immediate impact on certain movementdisorder symptoms than coordinated reset stimulation. A clinician mayconclude that tonic stimulation in DBS may be beneficial for a patientfor a limited time while the patient is engaged in a specific activityor is experiencing one or more specific symptoms. The clinician maydefine different stimulation programs using a coordinated resetstimulation pattern and a tonic stimulation patterns and associate suchstimulation programs with different patient activities and/or patientconditions.

In 804, the clinician determines timing to apply stimulation programrelative to patient activity. For example, the clinician may determinethat a patient will receive the most benefit if a given stimulationprogram begins before the patient begins an expected activity.Alternatively, the clinician may conclude that a specific stimulationprogram should only be used when the patient is detected engaging in thespecific activity. In yet other cases, the clinician may observe that aspecific activity induces a patient condition (pain level) after somelag time. For example, a patient may exercise and not experience muchdifference in their subjective condition while actually exercising butmay experience increased pain some time after halting the exercise. Theclinician may conclude that a stimulation program to address theincrease in the patient's pain level is appropriate beginning thirtyminutes after completion of the given activity. As yet another example,the clinician may select different stimulation programs to be appliedrelative to the timing of the ingestion of medication or pharmaceuticalcompounds.

In some embodiments, other timing parameters defined by the clinicianmay control the relative amount of application of one or more of thestimulation programs. For example, tonic stimulation (whether for DBS,SCS, or other neurostimulation therapies) may be shown to develophabituation in patients. It posited that habituation may occur whetherlow frequency (below 100 Hz) or high frequency (e.g., 500 Hz-10,000 Hzor higher) or whether stimulation is applied with or withoutparesthesia. Although habituation has been observed for tonicstimulation, tonic stimulation may produce superior reduction inneurological symptoms (movement disorder symptoms as an examples) forpatients in specific circumstances and, perhaps, for short periods oftime. For example, a patient's perception of chronic pain may involve atemporary increased level of pain based on a temporary patient condition(possibly induced by a specific activity). In such cases, it may bepreferred to switch to tonic stimulation from other stimulation pattern(e.g., burst stimulation, high-frequency no-paresthesia stimulation,coordinated reset stimulation) for a limited period of time when pain isinduced by a specific stimuli (although the reverse may also be truewhere switching from tonic to non-tonic stimulation will produce animproved patient response in some cases). In any event, the switchbetween stimulation patterns may be limited by the clinician to adefined time limit. The patient response to different types ofstimulation may differ between patients and differ according todifferent activities. The ability to switch stimulation types accordingto patient and activity specific situations may improve patientoutcomes.

In some embodiments, the clinician may define one or more preferredpercentage parameters (e.g., 25% of the time in a day) that one or morespecific stimulation patterns are applied. The clinician could alsodefine the relative percentages of time that two or more differentstimulation patterns are applied (e.g., 75% of the time for burststimulation and coordinated reset stimulation and 25% of the time fortonic stimulation). The clinician may limit the number of hours of tonicstimulation to a specific time limit (e.g., four hours in a day). Withsuch limits, the clinician may also specific stimulation patterns forspecific activities (e.g., coordinated reset stimulation is preferredwhile the patient is sleeping or resting).

In 805, the clinician's determination of appropriate timing for thestimulation programs are encoded into stimulation profile instructions.In 806, the stimulation profile instructions are communicated to thepatient's controller device to control the patient's neurostimulation(which may include automated scheduling and balancing of patternsaccording to observed patient activity).

FIG. 9 depicts a flowchart of activities and operations to create astimulation schedule based on expected user activities according to someembodiments. In 901, the stimulation programs and stimulation profileare stored in patient controller device. The patient controller devicemay communicate directly with a clinician programmer to receive therelevant data. Alternatively, the patient controller device may receivethe relevant data during one or more remote programming sessions.

In 902, stimulation schedule is calculated. The calculation of thestimulation schedule may occur using software operations on the patientcontroller device. In alternative embodiments, the initial stimulationschedule may be calculated by software on a server of the remote caremanagement system. The calculation of the stimulation schedule may beginby referring to an expected schedule of patient activities that isgenerated by monitoring patient activities over a period of time. In afirst pass, the calculation of the stimulation schedule applies timingrules that uniquely require specific time periods for specificstimulation programs. For example, the clinician may have defined atiming rule for a specific stimulation program to be applied while thepatient is sleeping. The times that are not uniquely defined by suchclinician defined rules are left empty. The remaining times may befilled with selections from the available stimulation programs. Theselection may limit application of certain stimulation programsaccording to total time limits or percentage of time limits. With theseconstraints applied, various scheduling algorithms may be applied suchas random scheduling, shortest or longest time allocation scheduling(where the stimulation program with the shortest or longest allocatedtime is prioritized), priority scheduling (where specific stimulationprograms are provided a priority weight), round robin scheduling, or anyother suitable scheduling algorithm.

In 903, the patient controller device changes stimulationprograms/settings according to detected conditions, timing, activitiesand stimulation profile. That is, the patient controller receives datafrom sensors, receive user input for activities and patient conditions,receives location data indicative of the patient's location anddetermines the patient's current activity and condition. The patientcontroller device switches between stimulation programs based on thisdata. When the patient controller device detects a change in activity(e.g., indirectly through sensor data or directly through user input orby merely time of day based on the patient's activity profile), thepatient controller device communicates relevant data to the implantablepulse generator of the patient to apply a different stimulation programand/or stimulation parameters. In some embodiments, the patientcontroller may prompt the user to authorize the change before actuallycommunicating the stimulation modification signal to the patient'simplantable pulse generator. The patient controller device communicatesthe relevant data to the patient's implantable pulse generator usingwireless communication such as low energy BLUETOOTH™ communications toapply the change in stimulation.

In 904, the patient controller device detects performance of activitiesoutside of expected times. In 905, the stimulation schedule isrecalculated by the patient's external controller device (or by a remoteserver) based on the respective activity outside of an expected time.

FIG. 10 depicts a series of operations that may be performed by apatient controller device or a remote server to control neurostimulationapplied to a patient according to some embodiments. In 1001, a patientschedule is created for a given day based on previously observed patienthabits. The previously observed habits may be identified using sensorsand activity detecting algorithms as discussed in this application. In1002, the created patient schedule is modified based on observed patientactivities for the day (if rescheduling is being performed). Forexample, the patient may leave for work at an earlier time, have lunchat a later time, exercise at a different time, etc. The patient scheduleis modified to reflect actual, observed performance of activities as theactivities are detected by the patient's external controller device orother device.

For clinician rules that uniquely associate stimulation program withactivity, respective programs are assigned to time periods according toclinician based timing rules (1003). For example, the programmingclinician may assign a specific stimulation program for rest/sleepperiods of the patient and another specific stimulation program foractivities requiring substantial patient movement (e.g., work orexercise). The stimulation schedule is updated to assign suchstimulation programs to time periods for the respective activities.

The clinician may not specifically assign stimulation programs to everypossible activity of the patient. Accordingly, some time periods willnot have a specific program assigned at this initial stage. In 1004,time periods with unassigned stimulation programs are identified. Theclinician may assign one specific default stimulation program forgeneral use. Accordingly, in 1005, if a single default program isdefined for automated scheduling, assign default program to unassignedtime periods

Alternatively, the clinician may identify multiple suitable programs forthe patient which may possibly have different benefits or effects. Ifmultiple stimulation programs are assigned for use by clinician forautomated scheduling, respective stimulation programs are assigned(1006) to time slots in unassigned time periods according to cliniciandefined timing limitations and scheduling algorithm (round robin, randomselection, priority/weighted scheduling etc.). In some embodiments, abalancing of stimulation programs is applied using the schedulingalgorithm. For example, the patient's clinician may specify thatcoordinated reset should be applied for a specific percentage of timeand tonic stimulation should be applied another percentage of time.Alternatively, the clinician may specify that burst stimulation shouldbe applied for a percentage of time and high frequency tonic stimulationfor another percentage of time. The scheduling algorithm may assignthese stimulation programs to the unassigned time periods such that theoverall percentages are obtained for the given day.

In 1007, the completed or updated stimulation schedule is stored for usein applying stimulation programs.

Although certain embodiments of this disclosure have been describedabove with a certain degree of particularity, those skilled in the artcould make numerous alterations to the disclosed embodiments withoutdeparting from the spirit or scope of this disclosure. All directionalreferences (e.g., upper, lower, upward, downward, left, right, leftward,rightward, top, bottom, above, below, vertical, horizontal, clockwise,and counterclockwise) are only used for identification purposes to aidthe reader's understanding of the present disclosure, and do not createlimitations, particularly as to the position, orientation, or use of thedisclosure. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not limiting. Changes in detail or structure may be made withoutdeparting from the spirit of the disclosure as defined in the appendedclaims.

When introducing elements of the present disclosure or the preferredembodiment(s) thereof, the articles “a”, “an”, “the”, and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including”, and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As various changes could be made in the above constructions withoutdeparting from the scope of the disclosure, it is intended that allmatter contained in the above description or shown in the accompanyingdrawings shall be interpreted as illustrative and not in a limitingsense.

1. A method of providing neurostimulation to a patient, comprising:storing an activity profile for the patient in an external controllerdevice of a neurostimulation system of the patient, wherein the activityprofile links a plurality of patient activities to respective ones of aplurality of different stimulation programs for use by aneurostimulation system of the patient, wherein each stimulation programis adapted to provide a different stimulation effect on the patient;storing a plurality of clinician defined scheduling rules that definetime periods for provision of stimulation according to ones of theplurality of different stimulation programs based on performance ofrespective activities performed by the patient; monitoring activities ofthe patient using at least one external device; operating a stimulationprogram scheduling process in the external controller device of theneurostimulation system that controls when an implantable pulsegenerator of the neurostimulation system generates electrical pulsesaccording to ones of the plurality of different stimulation programswith different stimulation effects for application to neural tissue ofthe patient according to times defined by at least the activity profileand the scheduling rules.
 2. The method of claim 1 wherein the activityprofile defines expected times of performance of regularly performedactivities to control application of stimulation according to ones ofthe stimulation programs corresponding to the regularly performedactivities.
 3. The method of claim 1 wherein the scheduling rules definelengths of time for application of stimulation according to one of thestimulation programs when respective patient activities are detected. 4.The method of claim 1 wherein the scheduling rules define at least onestimulation program for application by the implantable pulse generatorafter a respective patient activity is completed.
 5. The method of claim1 wherein the scheduling rules define at least one stimulation programfor application by the implantable pulse generator while a respectivepatient activity is being performed.
 6. The method of claim 1 whereinthe monitoring activities of a patient includes repetitively detecting alocation of the patient using location determining circuitry of theexternal device of the patient.
 7. The method of claim 6 wherein thelocation determining circuitry comprises at least one set of circuitryfrom the list consisting of: cellular communication circuitry, WiFicircuitry, and Bluetooth circuitry.
 8. The method of claim 6 wherein themonitoring activities of the patient comprises detecting an amount oftime spent at an identified location.
 9. The method of claim 6 whereinthe monitoring activities of the patient comprises detecting signalsfrom one or more wireless beacon devices to perform microlocationprocessing.
 10. The method of claim 1 wherein the monitoring activitiescomprises obtaining data pertaining to physiological signals of thepatient using a wearable device.
 11. The method of claim 1 furthercomprises: communicating patient activity data to a remote caremanagement system, wherein the remote care management system determinesthe activity profile for the patient.
 12. The method of claim 11 whereinthe remote care management system performs an averaging calculation ofobserved times for patient activities of the activity profile.
 13. Themethod of claim 12 wherein the remote care management system calculatesaverage start times of respective activities for the activity profile.14. The method of claim 12 wherein the remote care management systemcalculates average end times of respective activities for the activityprofile.
 15. The method of claim 11 wherein the remote care managementsystem applies a calculation of frequency of performance of activitiesto determine the activity profile.
 16. The method of claim 11 whereinthe remote care management system applies an averaging calculation todetermine average duration of activities for the activity profile. 17.The method of claim 1 wherein the different stimulation programscomprise different stimulation amplitude levels for application ofelectrical pulses to the patient.
 18. The method of claim 1 wherein thedifferent stimulation programs apply electrical pulses at differentfrequencies.
 19. The method of claim 1 wherein the different stimulationprograms apply electrical pulses to different neural targets.
 20. Themethod of claim 1 wherein the different stimulation programs applyelectrical pulses using different stimulation patterns.
 21. The methodof claim 1 wherein the different stimulation programs cause differentside effects for the patient.
 22. The method of claim 1 wherein at leastone of the different stimulation programs is adapted to treat pain ofthe patient.
 23. The method of claim 1 wherein the plurality ofdifferent stimulation programs treat a motor disorder of the patient.